Jody brings to BDSI
a wealth of experience in this area, including the past 14 years overseeing this function for Salix.
BELBUCA is being developed and will be commercialized through a worldwide license and development agreement between Endo Pharmaceuticals and BDSI
Sirgo, president and Chief Executive Officer of BDSI
is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA) technology and other drug delivery technologies to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs.
In its claim, originally filed in the Federal District Court of New Jersey on November 2, 2010, and formally served on BDSI
on January 19, 2011, MonoSol claims that the manufacturing process for ONSOLIS infringes its patent.
We are very pleased to have found someone of Steve's caliber with such extensive and relevant experience to join BDSI
at such an important time in the growth of the company.
We continued our operational achievements while working to contain expenses and maintain our cash burn rate according to our operating plan over the first nine months of the year," said Ernest De Paolantonio, Chief Financial Officer of BDSI
approaching nearly $10 billion, we believe this represents a significant opportunity for BDSI
FDA approval of BELBUCA has triggered a milestone payment to BDSI
from Endo of $50 million pursuant to the 2012 worldwide license and development agreement between BDSI
and Endo for the development and commercialization of BELBUCA.
The issue has no impact on any other BDSI
product, including BELBUCA, which has a PDUFA date of October 23.
Andrew Finn, Executive Vice President of Product Development at BDSI
, "Given our clinical and regulatory success with the execution of the ONSOLIS program, we are confident in our ability to efficiently execute this program as planned.
The approval of BREAKYL is the result of a continued strong collaborative effort between BDSI